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Notification report


Full notification file


General information

Notification Number
B/ES/21/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
18/01/2021

Title of the Project
Clinical trial RSV PED-003 entitled: “A phase II, randomized, observer-blinded, controlled, multicenter trial to evaluate safety, reactogenicity, efficacy, and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) investigational vaccine based on the RSV viral proteins F, N, and M2-1 encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) when administered intramuscularly according to a 2-dose schedule to infants aged 3 to 7 months at first intervention administration.”

Proposed period of release:
01/06/2021 to 30/06/2023

Name of the Institute(s) or Company(ies)
GlaxoSmithKline Biologicals, Rue de l’Institut, 89
1330 Rixensart, Belgium;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Spain; Finland; Italy; Estonia; Poland; Bulgaria;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/ES/16/07;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Order of the parental organism: Adenoviridae
Genus of the parental organism: Mastadenovirus
Species of the parental organism: Simian Adenovirus Subgroup C


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Chimpanzee adenovirus type 155MastadenovirusSimian adenovirusN/Aserotype 155N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known